Vitamins, minerals, amino acids, and co-enzymes are compounds required by an animal or human body in small amounts for metabolism, biophysiological repair, to protect health, and for proper growth and cellular reproduction. These compounds also assist in the formation of hormones, blood cells, nervous-system chemicals, and genetic material. Vitamins, minerals, amino acids, and co-enzymes are often referred to as nutrients, defined herein as a substance or ingredient which may be found in food which imparts a medicinal or health benefit. The various nutrient compounds are not chemically related, and most differ in their physiological actions. They generally act as catalysts, combining with proteins to create metabolically active enzymes that in turn produce hundreds (or more) of important chemical reactions throughout the body. Without nutrients, many of these reactions would slow down or cease. The intricate ways in which nutrients act on the body (e.g., positive and negative feedback regulatory processes), however, are still far from clear.
Dietary supplements are generally nutrient mixtures commonly taken in single mega-dose dosage forms which contain vitamin, mineral and other nutrient doses. Although mega-dose regimens are a common practice for the prevention of disease, there is a great deal of debate in the conventional literature regarding the efficacy of such regimens. Moreover, consuming large doses of vitamins, minerals, or other nutrients, in the absence of some deficiency or without proper medical supervision, may cause harmful toxic effects and/or result in hypervitaminosis.
Additionally, a consumer usually has little choice in choosing the variety of ingredients, dosage levels, or dosing regimens of a conventional dietary supplement, such as a standard vitamin tablet. Conventional dietary supplements may be effective for a general purpose, but can provide an excess of vitamins, minerals, stimulants, or other compounds which a consumer does not desire, or those supplements may not adequately target an individual's specific dietary need or desired biological response. Additionally, conventional dosage forms of dietary supplements only allow a consumer to take one or two doses per 24 hour period. As a result, conventional dietary supplements fail to recognize that the physiological state and resultant nutrient requirements of any single individual can depend upon and fluctuate based upon a number of different biophysical variables during the course of each day or dosing regimen. For example, individual variations in diet, and the amount and intensity of physical activity, provide physical and chemical stimuli that stress various systems of the body to differing degrees from one person to the next and for each of those individuals on any given day. Thus, standard “one size fits all” mega-dose dosage forms/regimens are not amenable to empirical dosage adjustment to achieve an individualized biophysiological objective or response such as, but not limited to, enhanced sleep quality, initiation of sleep, sleep maintenance, and the like.
Another drawback with most conventional dietary supplements is that they suffer from poor degrees and/or rates at which the various nutrients are absorbed into the systemic circulation of the body and made available for biophysiological activity (e.g., “bioavailability”). These degrees or rates of bioavailability typically depend upon the dose, dosage form, and method of administration.
One particular barrier to efficient nutrient bioavailability is “first-pass metabolism”, which is defined herein to mean a process in which the nutrient compound(s) are modified, activated, or inactivated before they enter the systemic circulation, or are left unchanged and excreted. Alternatively, it may be defined as the intestinal and hepatic degradation or alteration of a drug or substance taken by mouth, after absorption, removing some of the active substance or nutrient from the blood before it enters the general circulation.
For example, it is generally understood by those skilled in at least the nutraceutical and/or supplements field that one significant drawback to “mega-dosing” of vitamins and minerals is that increased dosages may not be adequately absorbed into the body, or may actually decrease absorption. Thus, available transport mechanisms may become saturated and unable to absorb the excess dose of the vitamin, mineral, or other nutrient. Additionally, a drawback to vitamin or mineral delivery via a conventional tablet or capsule is that differences in luminal pH along the gastrointestinal tract lining, surface area per luminal volume, blood perfusion, presence of bile and mucus, and the nature of epithelial membranes may prevent or alter efficient absorption, activation, and the like of a nutrient, thereby decreasing its bioavailability and subsequent usage by the human body.
To compensate for first pass metabolism effects, some previous efforts have been directed to enterically coated tablet or capsule dosage forms which pass through the stomach unaltered to disintegrate in the lower intestines. However, aside from a delayed biophysiological response as gastric emptying becomes rate-limiting, gastric irritability, and potential allergic reactions from the ingestion of such coating materials occurs, and these enterically coated delayed release dosage forms dissolve and are absorbed within a narrow time frame. As a result, the body typically excretes the non-absorbed vitamins or minerals.
Additional previous attempts in addressing the challenge of bypassing first pass metabolism have been directed to continuous or gradual release dosage forms. U.S. Pat. No. 4,882,167, to Jang, discloses dry direct compressed products for controlled release of actives including vitamins or minerals. However, there still remains the challenge of a composition having ultra-low dosage amounts of vitamins or minerals, dosing flexibility, or alternatively systems, compositions, or methods for individualized responsive dosing based on at least one desired biological response such as increased sleep quality or treatment of a sleep disorder.
WO 99/17753 (to Awamura et al.) discloses rapidly dissolving films for delivery of drugs to be adsorbed in the digestive tract. U.S. Pat. No. 6,596,298, to Leung, discloses consumable oral care films which may optionally contain active amounts of pharmaceutical drugs. However, there still remains the challenge of utilizing vitamins or minerals, and more specifically, ultra-low dosage amounts of nutrients which would operate to provide flexibility for individualized dosing, especially in the promotion, enhancement or improvement in sleep initiation, maintenance, and/or quality. Moreover, these products or processes do not provide a system or selection for varying the type or level of dosage depending on a biological response desired, such as a focus upon sleep.
Therefore, there is presently a need for an efficient process for producing a nutrient dosage and delivery system that is capable of individualized biological response dosing (i.e., dosing based upon empirical analysis and adjustment in response to a desired biological outcome such as enhanced sleep quality and the like), which is available in a suitable dosage form, and preferably is efficiently absorbed and made bioavailable to animal or human tissue. Additionally, there is presently a need for a treatment method for managing finely tuned biological needs and responses which utilizes ultra low dosage amounts, substantially avoids first pass metabolism, and allows for varied dosage/dosing regimens within each dosing period (e.g., 24 hours, 6 hours, 1 hour). Furthermore, there exists a present need for an ultra low dose nutraceutical that substantially avoids first pass metabolism and which enhances sleep quality and/or can be used to treat sleep disorders including, but not limited to, sleep apnea.